Cytrellis Secures FDA Clearance for Full Body Resurfacing Using Ellacor® Micro-Coring® Technology

New indication significantly expands applications for ellacor to treat sagging skin on body areas outside of the face

WOBURN, Mass., Nov. 06, 2025 (GLOBE NEWSWIRE) — Cytrellis Biosystems, Inc. (“Cytrellis” or the “Company”), a medical aesthetics company bridging the gap in skin restoration, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for fractional skin resurfacing. This new indication expands ellacor’s use beyond the face, allowing medical professionals to perform ellacor procedures on any area of the body where skin laxity is a concern, such as the abdomen, knees or arms. This advancement validates the power and versatility of Cytrellis’ proprietary technology, unlocking new treatment opportunities across the growing non-surgical body aesthetics market.

“This clearance represents a major milestone for Cytrellis and for aesthetic medicine,” said Dr. Denise Dajles, President and Chief Executive Officer of Cytrellis. “Our mission has always been to deliver innovation that empowers providers and improves patient confidence. With this new indication, ellacor can now be used on-label anywhere on the body, offering physicians a powerful new option to remove and restore skin without surgery or heat-based energy.”

“The body aesthetics market is one of the fastest-growing segments in our field,” Dajles added. “With ellacor’s unique ability to remove skin tissue precisely and safely—without surgery or energy—we’re positioned to lead this next wave of innovation and consumer demand. It’s an exciting step forward for both our partners and their patients.”

Expanding Innovation Beyond the Face

ellacor’s Micro-Coring technology removes micro-cores of skin without surgery or the use of heat, offering a distinctive alternative to conventional skin tightening technologies such as fractional laser, RF microneedling, or high frequency ultrasound. By removing a fraction of the skin at a time and stimulating natural collagen and elastin production, ellacor achieves smoother, tighter, and more youthful-looking skin.

The expansion into body indications comes at a pivotal time, as consumer demand for non-surgical skin tightening and rejuvenation continues to grow rapidly. According to recent industry reports, creepy or sagging, loose skin & flabby arms are among top 5 body concerns consumers report wanting to eliminate, and up to half of GLP-1 users are now exploring non-surgical aesthetic options for sagging skin¹.

“ellacor allows physicians to treat skin without the use of energy, scarring, or surgery,” said Dr. William Austen, Cytrellis co-founder, Chief of Burn Surgery, Oral & Maxillofacial Surgery at Massachusetts General Brigham, and world-renowned plastic surgeon. “With a solid foundation of robust clinical data, this approach enables precise and controlled skin removal across multiple areas of the body.”

Dr. Rox Anderson, Cytrellis co-founder, Director of the Wellman Center for Photomedicine and Lancer Endowed Chair in Dermatology at Massachusetts General Brigham, and world-renowned dermatologist, added, “The ability to precisely remove micro-portions of skin anywhere on the body opens a new category of skin restoration. We’re proud to see years of research and collaboration with clinicians now translating into broader patient benefit.”

About Cytrellis Biosystems

Cytrellis Biosystems is an aesthetics medical device company advancing the frontier of skin restoration by creating evidence-based solutions that achieve consistent results and exceed the expectations of patients. Cytrellis manufactures ellacor^® with Micro-Coring^® technology, the only FDA-cleared non-surgical treatment that removes excess skin to address moderate and severe wrinkles. For more information, visit www.cytrellis.com and follow us on LinkedIn, Instagram, and Facebook.

1. New Beauty, The State of Aesthetics: By the Numbers Summer 2025

Contact:

Patty Caballero

patty@pscconsulting.net

973-348-5055